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NOT YET RECRUITING
NCT06909539
NA

HOme PElvic Floor Improvement Trainer Trial

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain. Investigators will test the utility of this device as a treatment alternative and/or temporary treatment for a patient's symptoms prior to or perhaps in lieu of their physical therapy appointment.

Official title: Using a Perineometer Device With Gamification to Improve Symptom Outcomes in Pediatric Pelvic Floor Dysfunction

Key Details

Gender

All

Age Range

8 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-06-01

Completion Date

2027-01-01

Last Updated

2025-04-24

Healthy Volunteers

No

Interventions

DEVICE

Home Pelvic Floor Trainer

The intervention utilizes a perineometer device with biofeedback features. This device employs external electrodes to measure pelvic floor muscle strength. It then provides real-time feedback through a smartphone application during exercise sessions. The application uses gamification to engage users and track progress. Patients can choose between two games: a bird game or a space-themed game. In the bird game, patients activate their pelvic floor muscles to make the bird fly upward. In the space game, pelvic floor contractions fire a laser or activate a shield. A visual bar displays the strength of pelvic floor contractions. Games are designed to be played for 5 minutes daily, 7 days a week, with increasing difficulty as the user progresses through levels.

Locations (1)

University of Colorado Anschutz

Aurora, Colorado, United States